Effects of Dry Eye Treatments on the Ocular Surface

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01797822
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 33.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate whether, in people with dry eye syndrome, over the counter artificial tears and the prescription eye drop, dexamethasone, change or effect the eyes response to a low humidity environment.

It is known that irritation from dry eye can be improved by over the counter artificial tears because they wet and lubricate the eyes. The prescription eye drop, dexamethasone, can also improve eye irritation by decreasing the inflammation that develops in dry eye. Thus, the investigators hypothesize that the use of these conventional dry eye treatments will improve the eyes' response to a low humidity environment.

Condition or Disease	Intervention/Treatment	Phase
Keratoconjunctivitis Sicca; Dry Eye Syndrome	Drug: Dexamethasone; Drug: Artificial tear	Phase 4

Detailed Description

This study evaluated the effects of the corticosteroid dexamethasone on suppressing development of eye irritation, cornea epithelial disease and increased production of inflammatory mediators in subjects who were subjected to an experimental low humidity drafty environment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Vehicle and therapy groups were not masked.
• Primary Purpose: Treatment
• Official Title: Effects of Conventional Dry Eye Treatments on the Ocular Surface Response to Low Humidity Environment in Patients With Keratoconjunctivitis Sicca.
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Artificial tears first, then Dexamethasone Artificial tears four times a day both eyes for two weeks, then Dexamethasone 0.01% four times a day both eyes for two weeks	Drug: Dexamethasone; Other Names: corticosteroid, vehicle ; Drug: Artificial tear

Outcome Measures

Primary Outcome Measures

1. Changes in Corneal Fluorescein Staining [Two weeks after treatment and exposure to a low humidity environment]

   Subjects will be treated with preservative-free artificial tears for 2 weeks then exposed to a low humidity environment for 90 minutes, then treated with preservative-free dexamethasone 0.1% for 2 weeks and exposed to a low humidity environment again. The change in corneal fluorescein staining before and after the low humidity exposure was measured after each treatment. Fluorescein staining was graded using the CCLR scale (0-100) in 5 zones on the cornea for a maximum score of 500 (range 0-500). A lower change in staining indicates less severe disease in response to the low humidity stress. Negative number indicates staining after exposure was lower than pre.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Signature on the written informed consent form

• Patient motivation and willingness to cooperate with the investigator by following the required medication regimen

• Patient willingness and ability to return for all visits during the study

• Rapid tear film break up time of seven seconds or less in at least one eye AND

• Both cornea fluorescein staining score 3 or greater and conjunctival lissamine green staining 3 or greater in at least one eye

• Ocular Surface Disease Index Symptom Severity score of twenty or greater

• Tear meniscus height less than or equal to 200um

• Intact corneal sensitivity

• Willingness to discontinue use of any current dry eye treatment (except artificial tears) for four weeks prior to enrollment, and during the course of the study

Exclusion Criteria:

• Compromised cognitive ability which may be expected to interfere with study compliance

• Uncontrolled or poorly controlled diabetes or heart or pulmonary disease that could, in the judgment of the investigator, jeopardize subject safety or interfere with the interpretation of the results of the study

• Known hypersensitivity to any components of the artificial tears or dexamethasone eye drops

• Anticipated contact lens wear during the study

• History of corneal transplant

• Active ocular infection, uveitis or non-Keratoconjunctivitis sicca related inflammation

• History of cataract surgery within 3 months prior to enrollment

• History of pterygium removal within 6 months prior to enrollment

• Reduced corneal sensitivity

• Initiation, discontinuation or change in dosage of hormone replacement therapy, fish oil, evening primrose, flaxseed, or black current seed oil supplements, antihistamines, cholinergic agents, beta-blocking agents, tricyclic or selective serotonin reuptake inhibitors, antidepressants, phenothiazines, or topical or systemic acne rosacea medications in two months prior to enrollment, or anticipated change in dosage during course of study

• Topical ophthalmic medications within prior 4 weeks, or anticipated use of same during the study (except artificial tears)

• Occlusion of the lacrimal puncta either surgically or with temporary collagen punctal plugs within three months prior to study, or anticipated use of same during study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baylor College of Medicine, Alkek Eye Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Baylor College of Medicine

Investigators

• Principal Investigator: Stephen Pflugfelder, MD, Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steven Pflugfelder, Professor of Ophthalmology, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT01797822
• Other Study ID Numbers: H-31756
• First Posted: Feb 25, 2013
• Last Update Posted: Feb 5, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis; Dexamethasone; Lubricant Eye Drops

Study Results

Participant Flow

Arm/Group Title	Artificial Tears First, Then Dexamethasone 0.01%
Arm/Group Description	Artificial tears four times a day for two weeks in both eyes, then Dexamethasone 0.01% ophthalmic solution four times a day for two weeks in both eyes
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Dexamethasone, Artificial Tears
Arm/Group Description	Dexamethasone 0.01% ophthalmic solution four times a day for two weeks in both eyes Artificial tears four times a day for two weeks in both eyes dexamethasone, artificial tears
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	17 85%
>=65 years	3 15%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.25 (14)
Sex: Female, Male (Count of Participants)
Female	20 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Changes in Corneal Fluorescein Staining
Description	Subjects will be treated with preservative-free artificial tears for 2 weeks then exposed to a low humidity environment for 90 minutes, then treated with preservative-free dexamethasone 0.1% for 2 weeks and exposed to a low humidity environment again. The change in corneal fluorescein staining before and after the low humidity exposure was measured after each treatment. Fluorescein staining was graded using the CCLR scale (0-100) in 5 zones on the cornea for a maximum score of 500 (range 0-500). A lower change in staining indicates less severe disease in response to the low humidity stress. Negative number indicates staining after exposure was lower than pre.
Time Frame	Two weeks after treatment and exposure to a low humidity environment

Outcome Measure Data

Analysis Population Description

difference (change) in fluorescein staining pre- and post-exposure to low humidity stress

Arm/Group Title	Artificial Tears	Dexamethasone
Arm/Group Description	Artificial tears four times a day for two weeks in both eyes/Artificial tears	Dexamethasone 4 times per day for 2 weeks in both eyes/Dexamethasone
Measure Participants	20	20
Mean (Standard Deviation) [units on a scale]	22.18 (22.03)	-3.35 (18.83)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Artificial Tears, Dexamethasone
	Comments
	Type of Statistical Test	Other
	Comments	Statistical comparison between groups was made with t-test. A sample size of 20 subjects was calculates to have 90% power of detecting a statistical difference (P<0.05) in change in corneal staining pre and post low humidity challenge.
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 1 sided
	Comments

Adverse Events

Time Frame	18 months
Arm/Group Title	Dexamethasone		Artificial Tear
Arm/Group Description	Dexamethasone 0.01% ophthalmic solution four times a day for two weeks in both eyes		Artificial tears four times a day for two weeks in both eyes
All Cause Mortality
	Dexamethasone		Artificial Tear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Dexamethasone		Artificial Tear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Dexamethasone		Artificial Tear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.